In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.

In this arm 2, patients were started or continued on their standard ARV drugs plus placebo capsule once daily at bedtime; in the 2nd and 3rd arms patients did not know whether they were taking Low-Dose Naltrexone or a placebo.

Other: ARV's + Placebo

Patients continued ARV's plus a placebo nightly for 9 months

Other Names:

Azidothimidine + lamivudine + nevirapine Or

Stavudine + lamivudine + nevirapine (TRIOMUNE)Or

Azidothimidine + lamivudine + efavirenz Or

Azidothimidine + lamivudine + lopinavir/r Or

Emtricitabine + tenofovir + efavirenz

Detailed Description:

The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.

Eligibility

Ages Eligible for Study:

18 Years to 60 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-1 infected

CD4 count over 350 (arm 1/group 1)

CD4 count over 200 and on ARV's (arms 2,3/groups 2,3)

Age between 18 & 60

Males or females

Exclusion criteria:

HIV-1 seronegative

HIV-2 infected

CD4 count lower than 200

patients under age 18

Those refusing to be in study

Pregnant or breast-feeding women

Patients under immuno-suppressor therapy

Those with renal or hepatic dysfunction

Malaria or tuberculosis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174914